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Levitra -- new treatment for erectile dysfunction -- gains U.S. approval

ROCKVILLE, MD., Aug. 20, 2003 -- The FDA has approved Levitra (vardenafil HCl), an oral medication to treat erectile dysfunction in men (impotence). This is the second oral product approved for the treatment of erectile dysfunction (see NOTE, below).

Co-developed and co-promoted by Bayer AG and GlaxoSmithKline, Levitra (pronounced Luh-VEE-trah) provides men with their first new ED treatment choice in five years. Levitra is expected to be available in pharmacies nationwide within the next few weeks.

Erectile dysfunction affects millions of men in the United States. Levitra acts by relaxing muscles in the penis and blood vessels, allowing increased blood flow into the penis, which produces an erection.

Levitra was evaluated in randomized, placebo-controlled trials involving more than 2000 men with erectile dysfunction. In two of the trials men had erectile dysfunction associated with diabetes mellitus or following radical prostatectomy for prostate cancer.

The drug's effectiveness was assessed using a sexual function questionnaire. In addition, patients were asked to report if they were able to achieve an erection adequate for intercourse and whether the erection was maintained to allow completion of intercourse. In all of the trials, Levitra improved patients' ability to achieve and maintain a penile erection.

The recommended dose is 10 mg taken 1 hour before sexual activity. A higher dose of 20 mg is available for patients whose response to the 10 mg dose is not adequate. Two lower doses (2.5 mg and 5.0 mg) are also available and may be necessary for patients taking other medicines or have medical conditions that may decrease the body's ability to metabolize vardenafil. Levitra should not be used more than once a day.

Levitra should not be used with nitrates (such as nitroglycerin tablets or patches) or with alpha-blockers (medicines used to treat benign prostatic hyperplasia and/or high blood pressure such as tamsulosin, terazosin, doxazosin, and alfuzosin) because the combination may significantly lower blood pressure and lead to fainting in some men. Currently there is no information available to support the safety of even the lower doses of vardenafil taken together with alpha-blockers.

In addition, Levitra should not be used in patients who have a rare heart condition known as "prolongation of the QT interval" because of the possibility of producing abnormal heart rhythm. This issue was discussed at a Cardio-Renal Advisory Committee Meeting on May 29, 2003, and the committee recommended drug approval.

Because some drugs may affect the metabolism of Levitra, patients should inform their doctors that they are taking Levitra and they should not begin taking new medicines without informing their doctor. For example, patients taking erythromycin should not take more than a 5 mg dose of Levitra and a maximum dose of 2.5 mg Levitra once every 72 hours is the maximum recommended dose for patients who are taking ritonavir.

Levitra should not be taken by men in whom sexual activity is inadvisable because of their underlying cardiovascular status (heart condition). Patients should inform their doctor about any heart problems they have experienced before taking Levitra.

Levitra is not recommended in patients who have suffered a heart attack or stroke within the last six months, or patients who have significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe liver impairment, end stage renal disease requiring dialysis, or retinitis pigmentosa (an eye disorder).

The most common side effects reported in clinical trials included headache, flushing, rhinitis, and indigestion. Dizziness was reported in about two percent of patients. A small number of patients taking Levitra also reported abnormal vision.

Before taking Levitra, patients are advised to undergo a thorough medical history and physical examination to diagnose the underlying cause of the erectile dysfunction and to identify appropriate treatment.

Levitra confers no resistance to AIDS or other sexually transmitted diseases.

Levitra is manufactured by Bayer Corporation in Germany and will be distributed by Glaxo Smith Kline. The drug is currently available in Europe.

NOTE: Pfizer, the maker of Viagra, has filed suit in the United States alleging that one of its patents would be infringed by the sale of Levitra. The case is in its early stages.

For more information about Levitra, visit www.Levitra.com

Sources: FDA; Bayer AG; GlaxoSmithKline plc

Web sites:
www.levitra.com
www.bayer.com
www.gsk.com

Posted: August 2003


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